Kornimate/medical-research-clean huggingface dataset:
team (thiotepa, etoposide, cytosar, melphalan ) for autosct in lymphoma

Conditions: Malignant Lymphoma

Summary: study is designed to explore whether the introduction of thiotepa, to the pre autologous stem-cell transplantation (asct) conditioning will reduce toxicity and thus improve outcome following transplantation in up to 24 patients with malignant lymphoma including both non-hodgkin's lymphoma (nhl) and hodgkin's lymphoma ( hl) improving toxicity profile , reducing side effects while potentially improving the antitumor response. specifically,we speculate that using the novel thiotepa based team consisted of thiotepa 5mg/kg on days -7-6, etoposide 200 mg/m2 , cytosar (ara-c) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1, pre transplantation conditioning regimen may allow transplantation with lower transplant related toxicity and thus improve outcome in this setting. toward this aim the impact on toxicity profile ,engraftment and disease control will be assessed.


Eligibility criteria:
inclusion criteria: 1. patients with non-hodgkin's and hodgkin's lymphoma as confirmed by a pathological biopsy report. 2. patients who are candidates for autologous stem-cell transplantation due to refractory or relapsing disease by standard institutional indications and comply with standard transplant eligibility criteria. 3. age less than physiologic 70 years. 4. patients with an adequate autologous stem cell collection for transplantation and backup (\>5 x 106 cd34(cluster of differentiation 34)+ cells/kg) .patients must sign written informed consent. 5. no limitation on bulky disease or bone marrow involvement. no limitation on the number and response to prior therapy. prior autologous transplantation and/or treatment with rituximab allowed. all prior chemotherapy completed at least three weeks before study treatment exclusion criteria: 1. bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit 2. creatinine \> 2.0 mg/dl 3. eastern cooperative oncology group (ecog) performance status \> 2 4. uncontrolled infection 5. pregnancy or lactation 6. abnormal lung diffusion capacity (dlco \< 40% predicted) 7. severe cardiovascular disease 8. cns (central nervous system) disease involvement 9. pleural effusion or ascites \> 1 liter 10. psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

Keywords: team (thiotepa, etoposide, cytosar, melphalan ) autologous stem-cell transplantation (asct) malignant lymphoma
a non-comparative study to assess the safety of mabthera (rituximab) in patients with rheumatoid arthritis.

Conditions: Rheumatoid Arthritis

Summary: this single arm study will assess the safety of mabthera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 dmards or biological agents. patients will receive mabthera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * rheumatoid arthritis \>=6 months; * lack of response to 1-5 dmards or biological agents; * rheumatoid factor positive. exclusion criteria: * other chronic inflammatory articular disease or systemic rheumatic disease; * joint or bone surgery during 8 weeks prior to randomization; * previous treatment with any cell-depleting therapy.
pathogenic metagenomic next-generation sequencing to optimize the diagnosis of decompensated cirrhosis infection

Conditions: Cirrhosis, Liver

Summary: the goal of this observational study is to learn about clinical application of pathogenic metagenomic next-generation sequencing to optimize the diagnosis of infection in decompensated cirrhotic patients. the main questions it aims to answer are: 1. mngs testing in optimizing anti-infective drug use in patients with acute decompensation, including response to empiric antibiotic therapy. 2. proportion of patients with re-compensation. 3. the positive rate of mngs in patients with acute decompensated cirrhosis and the characteristics of pathogen. 4. the incidence, risk factors and clinical correlation of cmv reactivation.

metagenomic next-generation sequencing (mngs) is emerging as an important culture-independent technique that can detect nearly all known pathogens simultaneously from a clinical sample.sequencing of microbial cell-free dna (cfdna) has recently been shown to enable diagnosis of several infection. relevant studies on the clinical application of mngs in cirrhosis patients are rare. the primary aim of this study was to comprehensively evaluate the fragments of genomic dna from circulating microorganisms in acutely decompensated cirrhosis patients by sequencing the microbial cfdna and relate this to clinical outcomes. the secondary aim was to validate the potential role of cmv reactivation, a known nhv with available antiviral medicines, in determining the prognosis of decompensated cirrhosis patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not. * acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy. exclusion criteria: * age \> 80 years old. * malignancy of liver or other organs (including leukemia). * receiving immunosuppressive agents for non-hepatic diseases. * hiv infection.
a study of abemaciclib in indian women with advanced breast cancer

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: the main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in indian women with advanced breast cancer. participants must have hormone receptor positive (hr+), human epidermal growth factor receptor 2 negative (her2-) breast cancer and must live in india. for each participant, the study could last up to eight months and may include up to eight visits to the study center.


Eligibility criteria:
inclusion criteria: * have a diagnosis of hormone receptor-positive (hr+), human epidermal growth factor receptor 2-negative (her2-) breast cancer * have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease * have postmenopausal status * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * have adequate organ function * have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy * are able to swallow oral formulation exclusion criteria: * have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. * have clinical evidence or history of central nervous system metastasis. * have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (cdk) 4 \& 6 inhibitor. * have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). seasonal flu vaccinations that do not contain a live virus are permitted. * have a personal history of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest. * have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years. * have received an autologous or allogeneic stem-cell transplant * have clinically relevant active bacterial or fungal infection, or detectable viral infection (for example, human immunodeficiency virus or viral hepatitis). screening is not required for enrolment. * are pregnant or breastfeeding.
phase ii trial of consolidative thoracic radiotherapy for extensive stage small cell lung cancer

Conditions: Extensive Stage Small Cel Lung Cancer

Summary: the majority of patients with small cell lung cancer have incurable extensive stage disease. the usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. despite this, the cancer usually returns. once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. these symptoms can worsen a patient's quality of life and in some situation be life-threatening. in this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. by giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.


Eligibility criteria:
inclusion criteria: * histologic or cytologic confirmation of small cell lung cancer * extensive stage disease * adequate pulmonary function tests (fev-1\>1.0, dlco\>50%) * patients of childbearing potential must practice adequate contraception * age ≧ 18 years * karnofsky performance status ≧ 70 * documented objective response to initial chemotherapy * signed study-specific informed consent form exclusion criteria: * complete or subtotal tumor resection * non-small cell histology * prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years * prior chest or neck rt * inadequate pulmonary function tests (fev-1\<1.0 or dlco\<50%) * pregnant

Keywords: small cell lung cancer radiotherapy
china peace-retrospective cathpci study

Conditions: Coronary Heart Disease

Summary: coronary heart disease (chd) is one of the leading causes of mortality and morbidity. pci, as a well-proved and booming measure in chd management, is invasive and of high cost, however the knowledge about the real-life pci use in china is limited. within a nation-wide and regional representative probability sample of hospitals in china, 14,000 cag/pci inpatient cases will be sampled randomly from 2001 to 2011. the sampled medical records will be reviewed and abstracted in the national coordinating centre, in order to evaluate the treatment pattern, outcomes, and cost for pci, during the past decade. basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve patients outcomes in future finally.

cardiovascular disease (cvd) is a major concern in public health globally, as well as in china, and remarkable variations of resources available and health system performance have been noted. relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. in addition, little information is available about the magnitude and quality of pci, which has developed rapidly during the past several decades. practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction. to investigate the treatment pattern and outcomes of pci during the past decade in china, using a stratified two-stage cluster sampling design, from 70 sampled hospitals, 7,000 cag/pci cases will be selected in 2011, and 3,500 in 2001 and 2006 separately. photocopies of the 14,000 medical records of cag/pci cases will be sent to the national coordinating centre. demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted by well trained professional abstractors. by characterizing differences in patients' features, comparing the use of medications and procedures, and examining the in-hospital outcomes, we'll define the gaps between clinical practice and guidelines, as well as the disparities across different regions and hospitals, to evaluated the treatment pattern and outcomes in the last decade in china. new knowledge will be generated about pci management all over china, to provide evidence for policy-making and clinical guidelines, and to improve patients prognosis in future finally.

Eligibility criteria:
inclusion criteria: * hospitalized patients undergoing a diagnostic cardiac catheterization and/or percutaneous coronary intervention (pci) for coronary lesions. exclusion criteria:
determining the optimal dose of reactive balance training after stroke

Conditions: Stroke

Summary: falls in daily life are one of the most significant complications for people with stroke. fall rates are particularly high soon after discharge from stroke rehabilitation. a new type of balance training, called reactive balance training (rbt), can reduce fall rates after discharge from stroke rehabilitation. in our previous study, rbt was implemented as part of routine care, and as a result, the dose of training was different for each participant; participants completed between one and twelve 30-minute sessions of rbt. previous research in healthy older adults suggests that a single session of rbt is enough to lead to lasting changes in reactive balance control and reduce fall rates in daily life. it is not clear if the same is true for people with stroke, who have more severe impairments and might need a higher dose of training to achieve the same benefits. the overall goal of this work is to determine the optimal dose of reactive balance training for people with stroke who are attending rehabilitation. this pilot study will determine the feasibility of a clinical trial to address this larger goal. people with sub-acute stroke will be randomly assigned to one of three groups: 1 session, 3 sessions, or 6 sessions of rbt. each session will be 45 minutes long, and will occur as part of participants' routine out-patient rehabilitation. we will use our experiences with this pilot study to help design a larger study. specifically, we will use this pilot study to answer the following questions: 1) what is the optimal sample size; 2) how long will it take to reach this sample size; 3) what outcome measures should be used; 4) how feasible is it to prescribe a specific dose of rbt to people with sub-acute stroke; and 5) what two intervention groups should be included in the larger trial?


Eligibility criteria:
inclusion criteria: * sub-acute stroke; * receiving out-patient rehabilitation at the toronto rehabilitation institute; * can stand independently for \>30 seconds; * can walk with or without a gait aid (but without assistance of another person) for \>10 metres; and * living in the community. exclusion criteria: * completed reactive balance training during in-patient rehabilitation; * lower-extremity amputation, weight-bearing restrictions, recent lower-extremity injury or surgery (e.g., fracture), acute back or lower-limb pain, halo, aspen collar, history of fragility fracture and/or severe osteoporosis/osteopenia, contractures that prevent neutral hip or ankle; * activity restrictions following cardiac event/surgery, abnormal or unstable cardiovascular responses to exercise, arterial dissection; * severe spasticity in the legs; * cognitive impairment (i.e., unable to understand the purpose of training and/or to provide informed consent); and/or * acute illness (e.g., vomiting, fever), extreme obesity (exceeds safety harness weight limits), colostomy bags, indwelling catheter, infection, pressure sore on pelvis or trunk.
screening to prevent colorectal cancer (stop crc) among at-risk chinese and korean american primary care patients

Conditions: Colorectal Cancer

Summary: the objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 chinese and korean american primary care patients.

this study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 chinese and korean american men and 200 chinese and korean american women aged 50 to 75 eligible for colorectal cancer screening. participants are recruited from primary care physician clinics. the study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. investigators in the study develop an individualized screening plan using a theory-based online decision counseling program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.

Eligibility criteria:
inclusion criteria: * male and female chinese and korean american patients aged 50 to 75, who are not up to date for colorectal cancer screening exclusion criteria: * those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.

Keywords: colorectal cancer screening asian americans patient navigation decision counseling program
intra-tumor injection of oncolytic viruses h101 combined with or without radiotherapy in refractory/recurrent gynecological malignancies

Conditions: Genital Neoplasms, Female

Summary: the purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses h101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. and further research the mechanism of oncolytic viruses h101.

patients with recurrent, radiation/chemotherapy-resistant gynecological cancer carry a poor prognosis. h101 is a recombinant human type-5 adenovirus (ad5), in which the e1b and e3 gene have been deleted. previous studies have shown that h101 has anticancer activity and safety in some solid tumors, but has little report in gynecological oncology. in this clinical trial, 60 recurrent or refractory gynecological cancer patients will be enrolled. based on individual conditions, all eligible patients are intra-tumor injected oncolytic viruses h101 within 5 consecutive days combined with or without radiotherapy in sequential, three weeks for a cycle (1-4 cycles totally). simultaneously, the tumor sample, peripheral blood, and urine specimen were collected on day1 and day5. local control rate and side effects are recorded respectively.

Eligibility criteria:
inclusion criteria: * written informed consent obtained. * age ≥ 18 years at the time of study entry. * histological or cytologically diagnosed gynecological malignancies. * failure to prior standard treatment (surgery, chemotherapy, radiotherapy); * refractory/recurrence/metastasis gynecological cancer * at least one measurable lesion according to the recist1.1. * cooperative oncology group-status (ecog status) 0-3. * the last treatment should be over 2 weeks. exclusion criteria: * history or evidence of active autoimmune disease that requires systemic treatment. * participated in other anti-tumor clinical trials within 4 weeks. * patients who have a contraindication to similar drugs. * that failure to follow up regularly.

Keywords: cervical cancer ovary cancer endometrial cancer vaginal neoplasms vulvar neoplasms h101
randomized controlled 8-week crossover evaluation of compression bandage systems for venous leg ulcers

Conditions: Venous Ulcer

Summary: the purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.

the purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers. the new bandage is a 2-layer compression system. it will be used over primary dressings to provide the compression that is beneficial to venous leg ulcers.

Eligibility criteria:
inclusion criteria: * venous leg ulcer * patient can walk exclusion criteria: * cancerous ulcers * diabetic foot ulcer
long-term qol in acute promyelocytic leukemia treated with ato or standard chemotherapy

Conditions: Acute Promyelocytic Leukemia

Summary: this is a prospective and international observational study run by the gimema. all data will be centrally collected and analyzed at the gimema data center in rome (italy). patients reported outcomes will be collected using internationally validated questionnaires.


Eligibility criteria:
inclusion criteria: * apl survivors enrolled in gimema apl0406 clinical trial and in first molecular cr after third consolidation treatment * written informed consent. exclusion criteria: * apl patients previously enrolled in gimema apl0406 trial who cannot be reached or who are lost to follow-up.

Keywords: quality of life acute promyelocytic leukemia ato